UK Clarifies RWD Collection Rules Under Early Access Scheme
New UK guidance says companies do not have to apply for clinical trial approval or ethics review to collect data on the clinical management of patients receiving unapproved drugs under an early access scheme. However, consent is needed where such data may have research value once collected.
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Legal clarity around the core principles of the UK’s early patient access scheme is expected to benefit the pharma industry, patients and healthcare professionals.
The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”
A novel TYK2 inhibitor and a drug to treat an ultra-rare genetic disorder are among products up for a marketing authorization opinion this week from the European Medicines Agency’s human medicines committee, the CHMP.